Devices

Breakthrough Devices Updated Final Guidance

FDA has published a guidance, Breakthrough Devices Program, describing policies the agency will use to implement sections of several laws that authorize that program. The document supersedes one issued on 12/18/2018.

The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions, FDA says. It is available for products that are subject to review under a PMA, 510(k), or de novo classification request.

The guidance says the program may also apply to certain devices that benefit populations affected by health and/or healthcare disparities, thus promoting and advancing health equity. And, under the SUPPORT Act, it may be available for certain non-addictive medical products to treat pain or addiction.

The guidance contains an Introduction, Program Principles, Designation Request, Program Features, and two Appendices.

In an accompanying statement, CDRH director Jeffrey Shuren says the guidance clarifies the agency’s current interpretation of the Breakthrough Device criteria. In particular, he says, the update explains that FDA’s interpretation of “more effective” is based on the totality of available information about the device, including the potential for the device to make a clinically meaningful impact, and the risks and benefits compared to standard of care. It also explains that FDA may consider improved accessibility of a device when evaluating if it could meet the first breakthrough criterion. Finally, it clarifies how FDA discloses the breakthrough status of designated devices once they receive marketing authorization.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome